Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT01905150
Description: According to clinicaltrials.gov.
Frequency Threshold: 5
Time Frame: Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
Study: NCT01905150
Study Brief: Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan, Oxaliplatin) for Pancreatic Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC G-FLIP in combination with Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C Vitamin C: High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM 14 None 0 14 9 14 View
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C. G-FLIP alone for 2 weeks, then G-FLIP + Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C. G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C 18 None 0 18 13 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT General disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View